DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to communications filed September 29, 2025.
Status of Claims
1. Claims 1-24, 26-29 and 31-37 are pending and currently under consideration for patentability.
Claims 25 and 30 are canceled and claims 33-37 are newly presented as of the September 29, 2025 claim amendment.
Response to Amendment
2. Applicant has amended claim 5 and canceled claim 30 to overcome the previously applied 35 U.S.C. 112(b) rejection; accordingly, these rejections have been withdrawn herein.
Response to Arguments
3. Applicant’s arguments with respect to claim(s) 1-32 have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Nishtala et al. (US PGPUB 2009/0030370) remains as the primary reference of rejection for disclosing a majority of the claimed invention, and Hannon et al. (US PGPUB 2015/0297863 A1) is newly presented as a secondary reference for addressing and rendering the amended claim limitations obvious.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
4. Claims 1, 6, 8-10, 16-24, 26-29 and 31-37 are rejected under 35 U.S.C. 103 as being unpatentable over Nishtala et al. (US PGPUB 2009/0030370) in view of Hannon et al. (US PGPUB 2015/0297863).
5. With regard to claims 1, 16-18, 36 and 37, Nishtala discloses a device (indwelling urinary drainage catheter, 10) in the form of a tube or catheter for draining and/or sealing a natural or artificial bladder outlet (bladder neck, 3; abstract; Figs. 1A, 2B, 6A, 9), comprising a shaft body (catheter shaft, 20) that can be applied from extracorporeal into a bladder (2) of a patient ([0032]), as well as a balloon (bladder inflatable element, 40 and urethral inflatable element, 42) that surrounds the shaft body (20) like a cuff and is placed in the bladder (2) for the purpose of a vesical anchoring of the shaft body in the bladder (Fig. 2B; [0032]; [0034]; [0035]).
However, Nishtala is silent in regard to the shaft body element being a molded part having a profile with a wavy corrugation, providing the shaft body with a radial stability and kink-free axial bending property, wherein the corrugated profile of the shaft body extends from the bladder to the urethral orifice of the patient or to a proximal end of the catheter, or is molded only into defined segments of the shaft body, where the catheter is positioned inside kinking or bending portions of the urethra, reducing the elastic erection effect of the shaft body inside the urethra, so as to reduce pressure induced tissue damage; wherein the corrugation is having a sinusoidal or a rectangular shape; and wherein the respective wave form can be molded into a ring-like or into a helical structure, characterized in that the distance (PPD) between the adjacent upper peaks and between the adjacent lower peaks of the wave profile is equal or less than the wave amplitude (AP) of the wave and is larger than one third of the wave amplitude.
However, Hannon discloses urinary catheters having varying flexibility (abstract; Figs. 1, 2, 24) comprising a urinary catheter body (10, 110) that can be applied from extracorporeal into a bladder of a patient ([0003]; [0007]; [0044]; Figs. 6, 7), wherein the catheter body (10, 110) is a molded part ([0011]; [0041]; [0068-0069]) having a profile with a wavy corrugation (two corrugated sections, 114, 118), providing the shaft body (110) with a radial stability and kink-free axial bending property ([0070-0071]), wherein the corrugated profile (114, 118) of the shaft body extends over the entire wall of the shaft body from the bladder (B) to the urethral orifice (U) of the patient or to a proximal end of the catheter (“the entirety of the urinary catheter body is corrugated”; [0074]), or is molded only into defined segments (114, 118) of the shaft body (110), where the catheter is positioned inside kinking or bending portions of the urethra (U), reducing the elastic erection effect of the shaft body (110) inside the urethra (U), so as to reduce pressure induced tissue damage ([0069-0071]); wherein the corrugation (114, 118 or entirety of 110) is having a sinusoidal or a rectangular shape (Fig. 24); and wherein the respective wave form can be molded into a ring-like or into a helical structure ([0068-0069]; Fig. 24), characterized in that the distance (PPD) between the adjacent upper peaks and between the adjacent lower peaks of the wave profile is equal or less than the wave amplitude (AP) of the wave and is larger than one third of the wave amplitude (Fig. 24; [0070—0075]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter shaft disclosed by Nishtala, to include wavy corrugations along its length, similar to that disclosed by Hannon in order to provide a catheter shaft which imparts sufficient flexibility to traverse portions of the urethra, while also being sufficiently rigid to be pushed through the urethra without collapsing or buckling, as suggested by Hannon in paragraph [0070]. Additionally, one having ordinary skill in the art would recognize that a catheter shaft with wavy corrugations allows for a more flexible shaft while resisting kinking.
6. With regard to claim 6, Nishtala discloses that the balloon (40, 42) is filled or fillable with air or another gaseous medium ([0033]; [0042]; [0047]).
7. With regard to claim 8, Nishtala discloses a feed line (infusion lumens, 26, 28), which is integrated into a wall of the balloon-supporting shaft body (20) and which communicates with the balloon (40, 42), for conducting a filling medium into the balloon (40, 42; Figs. 1B, 6A; [0033]; [0034]; [0036]; [0041]).
8. With regard to claim 9, Nishtala discloses a feed line gap between a proximal end of the balloon (40, 42) and an outer surface of the shaft body (20) for conducting a filling medium into the balloon (40, 42; Figs. 1B, 6A; [0033]; [0034]; [0036]; [0041]).
9. With regard to claims 10 and 33, Nishtala discloses a feed line (26, 28), that is positioned inside the urine draining lumen of the catheter shaft (20), connecting to the catheter balloon (40, 42) through a perforation of the shaft body (20) and connecting outside of the body of the patient to a terminal, one-way valve ([0002]), which opens when a filling syringe is applied and automatically closes when a syringe cone is removed (Figs. 6A-6C; [0033]; [0034]; [0036]; [0041]).
10. With regard to claim 19, Nishtala discloses that the balloon (40, 42) consists of a single continuous balloon envelope (Fig. 6A; [0041]).
11. With regard to claims 20-23, 34 and 35, Nishtala, as modified by Hannon above, discloses the device according to claim 1, further Nishtala discloses that the TU portion of the balloon (42) has one balloon compartment that attaches to a vesical balloon (44, 45, 44’, 45’, 48) in the proximal direction and are constructed of separated molded balloon elements, which are arranged together in direct succession; the segment of the shaft body that is carrying the vesical balloon and optionally the vesical balloon portion is reinforced by a separately manufactured, tube-like component of elastic material ([0034]), keeping the draining lumen of the shaft body inside the vesical balloon and optionally the vesical balloon portion open, withstanding a collapse of the lumen at normal intra-vesical pressure; characterized in that the lumen reinforcing tube-like element is made from extruded tubing or made by an injection molding process or casting process; characterized in that the tube- like reinforcing component is carrying a specifically shaped tip formation, facilitating the atraumatic trans-urethral insertion of the catheter through the urethra of the patient, e.g. a so called Tieman tip formation. (Figs. 2A-2C, 3A, 5B; [0036-0039]; [0045]).
12. With regard to claims 24, 26-29 and 31-32, Nishtala, as modified by Hannon above, discloses the device according to claim 1, further Nishtala and Hannon discloses that both, the balloon and the shaft body are molded from a single piece of pre-extruded tubing, and whereby the distal, free balloon end is folded back over the shaft body and glued or welded to the outer surface of the shaft body, thereby forming a fillable balloon compartment; the corrugated profile of the shaft body is reaching from the bladder to the urethral orifice of the patient or to the proximal end of the catheter, or is molded only into defined segments of the shaft body, preferably where the catheter is positioned inside kinking or bending portions of urethra, reducing the elastic erection effect of the shaft body inside the urethra (Fig. 2B; [0032]; [0034]; [0035]), thus reducing pressure induced tissue damage; that the shaft body is able to be elastically deformed radially or is able to be radially folding or invaginating or collapsing inside the urethra by a regarding force exertion onto the shaft body, and is elastically erecting to its pre-formed profile and lumen, when the force exerted onto the shaft body is reduced; that the shaft body can be axially bent by 60 to 180 degrees, preferable by 90 to 180 degrees, whereby the draining lumen of the catheter is kept open or is only partially reduced, whereby a drainage occluding collapse or a kinking of the shaft body can be avoided; that the shaft body can be elastically detorqued in axial direction, spontaneously regaining the axially straightened pre-formed shape, when the torquing force is released; that the shaft body can be axially stretched to a larger length when exerting an axially directed pull force from the outside to it, and is elastically regaining its pre-formed length, once the axially stretching force is released; alternatively to a partial filling, the balloon body can also be filled with a volume that corresponds to or slightly exceeds the volume of the freely shaped balloon; and that the wavy corrugated shaft body, made from elastically deforming and erecting material, at axial bending of the shaft, is developing a decreased erecting force, elastically straightening the shaft back to its molded shape, avoiding or reducing permanent pressure exertion onto catheter exposed tissues (Fig. 2B; [0032]; [0034]; [0035]; [0045]).
13. Claims 2-5, 7, 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Nishtala in view of Hannon, as applied to claim 1 above, and further in view of Gobel (US PGPUB 2008/0125757).
14. With regard to claim 2, Nishtala and Hannon are silent in regard to the balloon being made from a thin-walled balloon soft-foil material, having a wall-thickness of 5 to 15 micron, and/or is manufactured by a blow-molding process from a pre-extruded tubing.
However, Gobel discloses a similar indwelling urinary catheter (abstract; Figs. 1, 2) wherein the balloon (30) is made from a thin-walled balloon soft-foil material ([0017]; [0024]), having a wall-thickness of 5 to 15 micron, and/or is manufactured by a blow-molding process from a pre-extruded tubing ([0026]; [0031]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the balloon disclosed by Nishtala in view of Salama to be made from a thin-walled balloon soft-foil material, similar to that disclosed by Gobel, in order to grant the balloon with compliance characteristics securing the shaping-of a retention body, not breaking out or bulging in shape to such a degree that the balloon can be luxated into or through the urethra, as suggested by Gobel in paragraph [0026].
15. With regard to claim 3, Nishtala and Salama are silent in regard to the balloon being already pre-shaped to its working dimensions and that it rests upon the shaft body in an only incompletely filled, flaccid state, the filling pressure inside the balloon thereby adapting toa pressure that is acting inside the bladder physiologically.
However, Gobel discloses a similar indwelling urinary catheter (abstract; Figs. 1, 2) where the balloon (30) is already pre-shaped to its working dimensions during manufacture and that it rests upon the catheter shaft (20) in an only incompletely filled, flaccid state, the filling pressure inside the balloon thereby adapting toa pressure that is acting inside the bladder physiologically ([0018]; [0035]; [0037]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the balloon disclosed by Nishtala in view of Salama to be pre-shaped to its working dimensions during manufacture and rest upon the shaft body in an only incompletely filled, flaccid state, similar to that disclosed by Gobel, in order to enable the balloon under low force exertion to conform to the anatomical structures which it is resting upon, thereby preventing exertion of force peaks and any resulting ulcers on the prominent bladder structures, and effectively increase the seal of the balloon with internal urethral orifice, as suggested by Gobel in paragraph [0035].
16. With regard to claim 4, While Nishtala discloses that the balloon (40, 42) consists of an elastomeric material ([0034], and that the balloon (40, 42) is configured with thin walls in order to inflate upon the presence of internal pressure ([0042]), Nishtala and Salama are silent in regard to an envelope of the balloon having a higher durometer reading of 90A to 95A and/or 55D to 65D on the Shore scale.
However, Gobel discloses the use of a polyurethane balloon (30) having a Shore hardness of 70A to 90A ([0046]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the balloon disclosed by Nishtala in view of Hannon to have a Shore hardness of 90A to 95A, similar to that disclosed by Gobel, in order to provide a balloon having sufficient hardness for providing the desired catheter anchoring to perform indwelling bladder drainage. Additionally, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP § 2144.07. Nishtala discloses the use of elastomeric balloons in paragraph [0034] and Gobel discusses the use of polyurethane balloons with a 90A shore hardness in paragraph [0046]. Additionally, the use of a harder and more rigid rubber or polyurethane elastomer are known balloon materials used in the art, as made clear by Gobel.
17. With regard to claim 5, Nishtala discloses that the intra vesical catheter balloon (40, 42) comprises a urethral or trans-urethral elongation (TU) (42) which extends into a urethra at least to, or beyond, the structures of the pelvic floor of the patient for the purpose of a urethral or a trans-urethral sealing ([0032]; [0034]; [0040]), wherein the urethral or trans-urethral portion of the balloon is pre-formed with a "residual" diameter that exceeds a diameter of a urethral lumen of the patient ([0041]; [0051-0052]).
Further, Nishtala makes it clear in paragraph [0040] that its disclosed TU portion (42) ensures that urine does not leak near the bladder neck, migration of extra luminal bacteria around the catheter is believed to be minimized, sizing difficulties are overcome in that the urethral balloon provides a one size fits all capability to the catheter, and because the urethral balloon immobilizes the catheter upon inflation, thereby sealing the catheter within the urethra, a pistoning effect of the catheter (i.e., movement of the catheter shaft in both proximal and distal directions while the catheter is implanted) is prevented and the level of anchor strength required of the bladder inflatable element reduced, providing patient comfort and making size and shape of the catheter for different patients less critical.
18. With regard to claim 7, Nishtala and Hannon fail to explicitly disclose that the anchoring intra-vesical portion (IV) of the balloon and the sealing urethral or trans-urethral portion (TU) of the balloon placed in situ is designed for an incomplete or partial filling by a medium volume, which is dimensioned such that the balloon as a whole remains in a flaccid state of expansion, i.e. that the balloon wall is not exposed to a permanent expanding force.
However, Gobel discloses that the anchoring and sealing balloon (30) is preferably filled with an incomplete or partial filling medium volume, which is dimensioned such that the balloon as a whole remains in a flaccid state of expansion ([0037]; [0039]; [0043]; Fig. 2).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the balloon disclosed by Nishtala in view of Hannon to be filled with an incomplete or partial filling medium, which is dimensioned such that the balloon as a whole remains in a flaccid state of expansion, similar to that disclosed by Gobel, in order to enable the balloon to fully occupy the trigonum vesicae portion of the urinary bladder, thereby enabling a portion of the balloon to move into the transition portion between bladder trigonum and urethra, or the internal urethral orifice, as suggested by Gobel in paragraph [0037].
19. With regard to claim 11, Nishtala and Hannon fail to explicitly disclose that the urethral or trans-urethral portion (TU) of the shaft body is housed into a mechanically protecting, sheath-like, thin-walled and soft, non-fillable tube-foil component, reaching from the proximal end of the intra-vesical portion (IV) of the balloon or its urethral elongation into or through the urethra.
Howevere, Gobel discloses that the urethral or trans-urethral portion (TU) of the shaft body (52) is housed into a mechanically protecting, sheath-like, thin-walled and soft, non-fillable tube-foil component, reaching from the proximal end of the intra-vesical portion (IV) of the balloon or its urethral elongation into or through the urethra ([0024-0026]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the shaft body disclosed by Nishtala in view of Hannon to be made from a thin-walled balloon soft-foil material, similar to that disclosed by Gobel, in order to grant the body with a protective sheath having compliance characteristics securing the shaping-of a retention body, not breaking out or bulging in shape to such a degree that the balloon can be luxated into or through the urethra, as suggested by Gobel in paragraph [0026].
20. With regard to claim 12, While Nishtala discloses the use of antimicrobial compounds as inflation fluids which diffuse through the balloon (40, 42) and into the urethra and bladder to achieve hemostasis in urologic surgery ([0041]), Nishtala and Hannon silent in regard to providing an antibacterial coating on a surface of the balloon.
However, Gobel discloses an antibacterial coating (silver particle coating; [0015]; [0047-0048]) on the surface of the balloon (30; Figs. 1, 2).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the balloon disclosed by Nishtala in view of Hannon to include an antibacterial coating, similar to that disclosed by Gobel, in order to have an antimicrobial effect as well as to minimize the encrustation of urine based compounds on the outside as well as the inside surfaces of the balloon, as suggested by Gobel in paragraph [0015].
21. With regard to claim 13, While Nishtala discloses that composite construction of the catheter also permits variation of stiffness through material selection, meaning that the stiffness (e.g., soft, flexible, semi-rigid, etc.) and bending properties of the catheter can be adjusted according to patient need ([0043]), Nishtala and Hannon are silent in regard to the shaft body being made of PUR and/or materials with Shore hardness of 60A to 90A, or materials in the hardness range of 70A to 85A.
However, Gobel discloses that the shaft body (20) is made of polyurethane ([0028-0029]) and/or of materials with Shore hardness of 60 A to 90 A, preferably of materials in the hardness range 70 to 85 A ([0046]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the shaft body disclosed by Nishtala in view of Hannon to be made of PUR, similar to that disclosed by Gobel, in order to retain its rigidity or safety against buckling, as required for insertion into the urethra in patient applications, as suggested by Gobel in paragraph [0029].
22. With regard to claim 14, Nishtala and Hannon are silent in regard to an outer diameter of the shaft body (20) lying in a range of 2 to 6 mm or in a range of 3 to 5 mm.
However, Gobel discloses that the outer diameter of the draining shaft body (20) lies in a range of 2 to 6 mm, preferably in a range of 3 to 5 mm (4 mm - 6 mm for adults; [0006]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the shaft body disclosed by Nishtala in view of Hannon to have an outer diameter in a range of 4 to 6 mm, similar to that disclosed by Gobel, in order to fit safely through the urethra of an adult, as suggested by Gobel in paragraph [0006]. Further, it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04(IV)(A). One having ordinary skill in the art would look to determine an optimum or workable shaft body diameter to safely fit through an adults urethral lumen in order to perform the desired bladder drainage.
23. With regard to claim 15, Nishtala and Hannon silent in regard to the wall thickness of the shaft body (20) being in a range of 0.1 mm to 0.5 mm.
However, Gobel discloses that the wall thickness (of 20) lies in a range of 0.1 mm to 0.5 mm (0.4 mm to 0.6 mm; [0029]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the shaft body disclosed by Nishtala in view of Hannon to have a wall thickness between 0.4 mm to 0.6 mm, similar to that disclosed by Gobel, in order to retain its rigidity or safety against buckling, as required for insertion into the urethra in patient applications, as suggested by Gobel in paragraph [0029].
Conclusion
24. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
25. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached on (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW J MENSH/Primary Examiner, Art Unit 3781